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Genmab — November 2018

Planlagt Fastgjort Låst Flyttet Genmab
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  • SolsenS Offline
    SolsenS Offline
    Solsen
    wrote on sidst redigeret af
    #409

    When dosing in iv was fixed it was on a very few pts I recall. So the higher conc. in blood could very well be a gamechanger.
    We know SAE is much better in sc and the bottleneck related to infusion time are gone with the 3-5 min sc

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    • SolsenS Offline
      SolsenS Offline
      Solsen
      wrote on sidst redigeret af
      #410

      Thanks bulder !

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      • JørgenVarnæsJ Offline
        JørgenVarnæsJ Offline
        JørgenVarnæs
        wrote on sidst redigeret af
        #411

        do we know that SC eliminates the initial administration issues?

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        • JørgenVarnæsJ Offline
          JørgenVarnæsJ Offline
          JørgenVarnæs
          wrote on sidst redigeret af
          #412

          or is that something we still need to see from the studies?

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          • E Offline
            E Offline
            E_L
            wrote on sidst redigeret af
            #413

            not a complete answer JV, but close, maybe we hear more in the actual presentation https://ash.confex.com/ash/2018/webprogram/Paper113590.html

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            • BulderB Offline
              BulderB Offline
              Bulder
              wrote on sidst redigeret af
              #414

              It looks like there still is a bit of IRRs in the first dose, but much les than IV: The incidence (16%) and severity of IRRs (mostly grade 1-2) with DARA SC was low, the majority of which occurred on Cycle 1 Day 1, and no discontinuations due to IRRs were observed.

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              • BulderB Offline
                BulderB Offline
                Bulder
                wrote on sidst redigeret af
                #415

                They still talk only about 3-5 minutes. Could be 5 minutes first time, then 3 min thereafter.

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                • E Offline
                  E Offline
                  E_L
                  wrote on sidst redigeret af
                  #416

                  It would be hard anyhow, right? with IV they often stop for a while/pauze on the first day in case of problems, but if you get a 5 minute shot, there is little time to stop lol

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                  • JørgenVarnæsJ Offline
                    JørgenVarnæsJ Offline
                    JørgenVarnæs
                    wrote on sidst redigeret af
                    #417

                    from what i recall - SC is being tested "stand-alone". The first dose is also SC. But I'm guessing an SC dose as an out patient is much easier/faster than the two-day IV first dose

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                    • JørgenVarnæsJ Offline
                      JørgenVarnæsJ Offline
                      JørgenVarnæs
                      wrote on sidst redigeret af
                      #418

                      Bulder - do you know if SC first dose is administered at home or under supervision?

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                      • JørgenVarnæsJ Offline
                        JørgenVarnæsJ Offline
                        JørgenVarnæs
                        wrote on sidst redigeret af
                        #419

                        But SC administration will eliminate the bottleneck issues no matter where it is administered

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                        • BulderB Offline
                          BulderB Offline
                          Bulder
                          wrote on sidst redigeret af
                          #420

                          In a clinic. According to Winkel home-administration is not possible at all.

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                          • JørgenVarnæsJ Offline
                            JørgenVarnæsJ Offline
                            JørgenVarnæs
                            wrote on sidst redigeret af
                            #421

                            also for the subsequent doses?

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                            • BulderB Offline
                              BulderB Offline
                              Bulder
                              wrote on sidst redigeret af
                              #422

                              Could be a good Q for the Q&A

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                              • E Offline
                                E Offline
                                E_L
                                wrote on sidst redigeret af
                                #423

                                Do I have this right on AMG420; they started this study in 2015, recruited only 35 patients of which 21 had disease progression , but they are talking positive about the 5(!!) that are still remaining?

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                                • BulderB Offline
                                  BulderB Offline
                                  Bulder
                                  wrote on sidst redigeret af
                                  #424

                                  I don't know if they have a hjemmesygeplejerske system in US. If they have home administration should be possible. If we talk about self-administration a syringe pump is nescessary. Then it takes 20 min as I remember it.

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                                  • E Offline
                                    E Offline
                                    E_L
                                    wrote on sidst redigeret af
                                    #425

                                    The Legend study to be honest i dont know. I also don't trust these guys…

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                                    • JørgenVarnæsJ Offline
                                      JørgenVarnæsJ Offline
                                      JørgenVarnæs
                                      wrote on sidst redigeret af
                                      #426

                                      I had a gander at the durability of the drug - seems if it is refrigerated dara has a shelf life of 24 months

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                                      • JørgenVarnæsJ Offline
                                        JørgenVarnæsJ Offline
                                        JørgenVarnæs
                                        wrote on sidst redigeret af
                                        #427

                                        you can keep dara in your fridge at home and shoot it just like insulin

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                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #428

                                          Who makes a Q to Winkel about this?

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